A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-993

NCT06508762 | Completed Phase 1 FDA Drug

• 1 other identifier: VX24-993-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-993 in healthy adult participants.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of VX-993

  From Day 1 up to Day 28

• Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993

  From Day 1 up to Day 28

• Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993

  From Day 1 up to Day 28

Secondary Outcomes (4)

• Maximum Observed Plasma Concentration (Cmax) of VX-993 Metabolite

  From Day 1 up to Day 28

• Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993 Metabolite

  From Day 1 up to Day 28

• Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993 Metabolite

  From Day 1 up to Day 28

• Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 1 up to Day 28

Study Arms (1)

VX-993

EXPERIMENTAL

Participants will be randomized to receive VX-993 in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two VX-993 formulations and the effect of food on the pharmacokinetics of VX-993.

Drug: VX-993

Interventions

VX-993 DRUG

Tablet and Suspension for Oral Administration.

VX-993

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
• A total body weight of more than (\>) 50 kg
• Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug

You may not qualify if:

• History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
• Any condition possibly affecting drug absorption, distribution, metabolism, or excretion

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

ICON Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: July 26, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)